Methamphetamine AbuseNCT03470480
rTMS for Craving in Methamphetamine Use Disorder
A study testing Real Repetitive transcranial magnetic stimulation, Methamphetamine visual cues and Neutral visual cues in people with Methamphetamine Abuse and Substance Use Disorders, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The primary aim of this project is to use a randomized single-blind sham-controlled study to investigate if high frequency repetitive transmagnetic stimulation (HF-rTMS) can modulate cue-induced craving in adult methamphetamine (METH) users. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Methamphetamine Abuse, Substance Use Disorders, Stimulant Dependence
- What is being tested?
- Real Repetitive transcranial magnetic stimulation, Methamphetamine visual cues and Neutral visual cues
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2018to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must use at least 0.5 g per day at least 5 days per week and have a minimum 12-month history of METH abuse.
- Subjects must meet DSM V diagnosis for methamphetamine use disorder.
- Subjects must have a minimum 4-week period of detoxification and a desire to stop using methamphetamine.
Who cannot join
- Present or past history of neurological disorder
- The present history of a DSM IV Axis I or DSM V primary psychiatric disease (apart from MUD and depressive symptoms defined as a Hamilton Depression Scale Score < 7 ("normal"))
- Scores on the Hamilton Depression Scale > 8, possibly indicating clinical depression
- No current abuse of drugs other than methamphetamine (except nicotine). Urine-screening tests for psychoactive drugs will be performed to corroborate the lack of drug use.
- Individuals meeting criteria for cannabis use disorder or alcohol use disorder
- Medical illness that can affect brain function
Show all 11Show fewer
- Past or present history of cardiovascular disease or high blood pressure
- Any history of epilepsy or a known history of seizure disorder
- A history of metal in the head or chest area (except dental fillings or braces)
- Current consumption of psychiatric medication
- Any other medical, neurological or neurosurgical condition that would preclude the administration of repetitive transmagnetic stimulation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Holly McCready contact
United States1 site, 1 recruiting
- Recruiting
Veterans Affairs Portland Health Care System
Portland, Oregon, 97239
Brandon J Cornejo, MD, PhD, 503-721-7964
Holly McCready, 503-721-7964
About this study
Official title: The Use of Repetitive Transmagnetic Stimulation to Target Craving in Methamphetamine Use Disorder
The primary aim of this project is to use a randomized single-blind sham-controlled study to investigate if high frequency repetitive transmagnetic stimulation (HF-rTMS) can modulate cue-induced craving in adult methamphetamine (METH) users. The investigators hypothesize that HF-rTMS directed at left dorsolateral prefrontal cortex (DLPFC) will result in a reduction in craving for METH compared to sham-controlled rTMS in adults with methamphetamine use disorder (MUD) as evidenced by validated measures of METH craving. Neurobiologically, the investigators anticipate rTMS mediated stimulation of the DLPFC could result in inhibition of cue-induced craving through potential disruption of involved circuitry. The current project proposes that participants who are recently abstinent from METH will be randomized into four experimental groups to provide two rTMS conditions (real versus sham) and two picture cues conditions (METH versus neutral). The experiment will have an induction phase where each subject will receive 10 daily treatments within 2 weeks. Just before each rTMS/sham session participants will be shown visual cues (METH or neutral). Participants will then undergo a maintenance phase for an additional month with assessments to evaluate craving and relapse. Urine samples for urine drug screening (UDS) will be collected at screening day and on days 1, 5 and 10. Just before each rTMS/sham session participants will be shown visual cues (METH and neutral). VAS craving scores will be assessed before and after picture presentation and after the rTMS/sham session. Before the first and 10th treatment session, participants were evaluated by the the Stimulant Craving Questionnaire (STCQ) and the Severity of Dependence Scale (SDS) questionnaires. Participants will then undergo a maintenance phase for an additional month. During the first week of maintenance, three rTMS/sham sessions will be administered. During each of the following 3 weeks, one rTMS/sham session will be given per week. As with the induction phase, urine samples will be collected for screening and STCQ and the SDS questionnaires will be completed at each maintenance session. To evaluate the long-term effects of the rTMS treatment, the investigators plan on contacting participants 6 months after treatment termination for all subjects who completed the 10 treatment sessions. During that phone conversation, craving and relapse will again be assessed.
- Conditions
- Methamphetamine Abuse, Substance Use Disorders, Stimulant Dependence, Methamphetamine-dependence, Stimulant Use, Transcranial Magnetic Stimulation
- Being tested
- Real Repetitive transcranial magnetic stimulation, Sham Repetitive transcranial magnetic stimulation, Methamphetamine visual cues, Neutral visual cues
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real Repetitive transcranial magnetic stimulationDevice
Also called rTMS, TMS, Magstim Rapid 2
A real magnet will be used during rTMS treatments, which will look identical to the sham magnet. The participants and treatment facilitator will be blinded to which magnet will be used. High frequency repetitive transmagnetic stimulation (rTMS) will be directed at left dorsolateral prefrontal cortex (DLPFC) during 10 daily treatments within two weeks then 6 more treatments during the following month.
Sham Repetitive transcranial magnetic stimulationDevice
A sham magnet will be used during rTMS treatments, which will look identical to the real magnet. The participants and treatment facilitator will be blinded to which magnet will be used. The sham rTMS treatments will be directed at left dorsolateral prefrontal cortex (DLPFC) during 10 daily treatments within two weeks then 6 more treatments during the following month.
Methamphetamine visual cuesBehavioural
Just before each rTMS session, participants will be shown methamphetamine-related pictures
Neutral visual cuesBehavioural
Just before each rTMS session, participants will be shown neutral pictures
| Study group | Role | What they receive |
|---|---|---|
| Treatment rTMS + meth pictures | Experimental | Participants in this group will receive real repetitive transcranial magnetic stimulation treatments. Before each rTMS session they will be exposed to a series of methamphetamine-related pictures to evaluate response to methamphetamine visual cues while receiving real rTMS treatments. This group will be referred to as real METH (RM). Receives: Device: Real Repetitive transcranial magnetic stimulation; Behavioral: Methamphetamine visual cues |
| Treatment rTMS + neutral pictures | Active comparator | Participants in this group will receive real repetitive transcranial magnetic stimulation treatments. Before each rTMS session they will be exposed to a series of neutral pictures to evaluate response to neutral visual cues while receiving real rTMS treatments. This group will be referred to as real neutral (RN). Receives: Device: Real Repetitive transcranial magnetic stimulation; Behavioral: Neutral visual cues |
| Sham rTMS + meth pictures | Sham comparator | Participants in this group will receive sham repetitive transcranial magnetic stimulation treatments. Before each rTMS session they will be exposed to a series of methamphetamine-related pictures to evaluate response to methamphetamine visual cues while receiving sham rTMS treatments. This group will be referred to as sham METH (SM). Receives: Device: Sham Repetitive transcranial magnetic stimulation; Behavioral: Methamphetamine visual cues |
| Sham rTMS + neutral pictures | Sham comparator | Participants in this group will receive sham repetitive transcranial magnetic stimulation treatments. Before each rTMS session they will be exposed to a series of neutral pictures to evaluate response to neutral visual cues while receiving sham rTMS treatments. This group will be referred to as sham neutral (SN). Receives: Device: Sham Repetitive transcranial magnetic stimulation; Behavioral: Neutral visual cues |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of rTMS directed at left DLPFC on craving for methamphetamine as assessed by the Severity of Dependence Scale.
The Severity of Dependence Scale (SDS) is a 5-item questionnaire that provides a score indicating the severity of dependence on methamphetamine. Each of the five items is scored on a 4-point scale (0-3). The total score is obtained through the addition of the 5-item ratings and will range from 0 to 15. The higher the score the higher the level of dependence. Pre and post differences in craving will be assessed.
Measured: 6 weeks
Effect of rTMS directed at left DLPFC on craving for methamphetamine as assessed by a Visual Analog Scale (VAS).
The visual analogue scale (VAS) is a fixed-length horizontal line on which the participant draws a line between the two anchors of "no cravings at all" and "most intense craving imaginable". The distance between the "no cravings at all" anchor and the participants line is measured and reported as a value between 0 and 100. The higher the value, the more intense the participants cravings are. Pre and post differences in craving will be assessed.
Measured: 6 weeks
Effect of rTMS directed at left DLPFC on craving for methamphetamine as assessed by the Stimulant Craving Questionnaire (STCQ).
The Stimulant Craving Questionnaire-Brief (STCQ) is a 10-item self-report measure that assesses current craving for methamphetamine, using a seven-point scale, with answers ranging from 0 ("strongly disagree") to 6 ("strongly agree"). A composite score is generated for each participant by averaging the responses over all 10 questions. The scores can range from 0 to 6. The higher the composite score, the stronger the current craving. Pre and post differences in craving will be assessed.
Measured: 6 weeks
Secondary outcomes (2)
Effect of craving for methamphetamine on relapse status after rTMS directed at left DLPFC.
Relapse will be determined by self-report and/or positive urine drug screens.
Measured: 5 months
Effect of cue type (methamphetamine versus neutral) on methamphetamine craving after rTMS treatment.
A composite craving score will be generated by adding each of the three craving measure scores (Severity of Dependence, Visual Analog Scale, and Stimulant Craving Questionnaire) for each participant who received real rTMS treatments. The composite score can range from 0 to 121, where 0 indicates no cravings for methamphetamine and 121 is the strongest possible cravings for methamphetamine. Pre and post differences in craving will be compared between participants who were exposed to methamphetamine cues before each session and those who were exposed to neutral cues.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2018
- Study start7 Feb 2018
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methamphetamine AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This preliminary study aims to consent and enroll 20 individuals with Methamphetamine Use Disorder. Participants will be randomized into two rTMS conditions (real versus sham) and two picture cues conditions (METH versus neutral). Randomization provides the following four groups: real METH (RM), real neutral (RN), sham METH (SM) and sham neutral (SN). The randomizations can be performed with a web-based randomization generator (www.randomization.com) (47). Subjects and rTMS administrators will be blinded to the treatment.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brandon Cornejo MD, PhD, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03470480
- Sponsor's protocol ID
- GPSYC0236A
- Status last verified
- Sep 2026
- First submitted
- 7 Feb 2018
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Repetitive Transmagnetic Stimulation to Target Craving in Methamphetamine Use Disorder
- ClinicalTrials.gov ID
- NCT03470480
- Acronym / sponsor ID
- GPSYC0236A
- Conditions
- Methamphetamine Abuse, Substance Use Disorders, Stimulant Dependence, Methamphetamine-dependence, Stimulant Use, Transcranial Magnetic Stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 7 Feb 2018 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 20 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim of this project is to use a randomized single-blind sham-controlled study to investigate if high frequency repetitive transmagnetic stimulation (HF-rTMS) can modulate cue-induced craving in adult methamphetamine (METH) users. The investigators hypothesize that HF-rTMS directed at left dorsolateral prefrontal cortex (DLPFC) will result in a reduction in craving for METH compared to sham-controlled rTMS in adults with methamphetamine use disorder (MUD) as evidenced by validated measures of METH craving. Neurobiologically, the investigators anticipate rTMS mediated stimulation of the DLPFC could result in inhibition of cue-induced craving through potential disruption of involved circuitry. The current project proposes that participants who are recently abstinent from METH will be randomized into four experimental groups to provide two rTMS conditions (real versus sham) and two picture cues conditions (METH versus neutral). The experiment will have an induction phase where each subject will receive 10 daily treatments within 2 weeks. Just before each rTMS/sham session participants will be shown visual cues (METH or neutral). Participants will then undergo a maintenance phase for an additional month with assessments to evaluate craving and relapse. Urine samples for urine drug screening (UDS) will be collected at screening day and on days 1, 5 and 10. Just before each rTMS/sham session participants will be shown visual cues (METH and neutral). VAS craving scores will be assessed before and after picture presentation and after the rTMS/sham session. Before the first and 10th treatment session, participants were evaluated by the the Stimulant Craving Questionnaire (STCQ) and the Severity of Dependence Scale (SDS) questionnaires. Participants will then undergo a maintenance phase for an additional month. During the first week of maintenance, three rTMS/sham sessions will be administered. During each of the following 3 weeks, one rTMS/sham session will be given per week. As with the induction phase, urine samples will be collected for screening and STCQ and the SDS questionnaires will be completed at each maintenance session. To evaluate the long-term effects of the rTMS treatment, the investigators plan on contacting participants 6 months after treatment termination for all subjects who completed the 10 treatment sessions. During that phone conversation, craving and relapse will again be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- This preliminary study aims to consent and enroll 20 individuals with Methamphetamine Use Disorder. Participants will be randomized into two rTMS conditions (real versus sham) and two picture cues conditions (METH versus neutral). Randomization provides the following four groups: real METH (RM), real neutral (RN), sham METH (SM) and sham neutral (SN). The randomizations can be performed with a web-based randomization generator (www.randomization.com) (47). Subjects and rTMS administrators will be blinded to the treatment.
| Arm | Type | Receives |
|---|---|---|
| Treatment rTMS + meth pictures | Experimental | Device: Real Repetitive transcranial magnetic stimulation, Behavioral: Methamphetamine visual cuesParticipants in this group will receive real repetitive transcranial magnetic stimulation treatments. Before each rTMS session they will be exposed to a series of methamphetamine-related pictures to evaluate response to methamphetamine visual cues while receiving real rTMS treatments. This group will be referred to as real METH (RM). |
| Treatment rTMS + neutral pictures | Active comparator | Device: Real Repetitive transcranial magnetic stimulation, Behavioral: Neutral visual cuesParticipants in this group will receive real repetitive transcranial magnetic stimulation treatments. Before each rTMS session they will be exposed to a series of neutral pictures to evaluate response to neutral visual cues while receiving real rTMS treatments. This group will be referred to as real neutral (RN). |
| Sham rTMS + meth pictures | Sham comparator | Device: Sham Repetitive transcranial magnetic stimulation, Behavioral: Methamphetamine visual cuesParticipants in this group will receive sham repetitive transcranial magnetic stimulation treatments. Before each rTMS session they will be exposed to a series of methamphetamine-related pictures to evaluate response to methamphetamine visual cues while receiving sham rTMS treatments. This group will be referred to as sham METH (SM). |
| Sham rTMS + neutral pictures | Sham comparator | Device: Sham Repetitive transcranial magnetic stimulation, Behavioral: Neutral visual cuesParticipants in this group will receive sham repetitive transcranial magnetic stimulation treatments. Before each rTMS session they will be exposed to a series of neutral pictures to evaluate response to neutral visual cues while receiving sham rTMS treatments. This group will be referred to as sham neutral (SN). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects must use at least 0.5 g per day at least 5 days per week and have a minimum 12-month history of METH abuse.
- Subjects must meet DSM V diagnosis for methamphetamine use disorder.
- Subjects must have a minimum 4-week period of detoxification and a desire to stop using methamphetamine.
Key exclusion criteria (11 listed)
- Present or past history of neurological disorder
- The present history of a DSM IV Axis I or DSM V primary psychiatric disease (apart from MUD and depressive symptoms defined as a Hamilton Depression Scale Score < 7 ("normal"))
- Scores on the Hamilton Depression Scale > 8, possibly indicating clinical depression
- No current abuse of drugs other than methamphetamine (except nicotine). Urine-screening tests for psychoactive drugs will be performed to corroborate the lack of drug use.
- Individuals meeting criteria for cannabis use disorder or alcohol use disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Real Repetitive transcranial magnetic stimulationAlso: rTMS, TMS, Magstim Rapid 2A real magnet will be used during rTMS treatments, which will look identical to the sham magnet. The participants and treatment facilitator will be blinded to which magnet will be used. High frequency repetitive transmagnetic stimulation (rTMS) will be directed at left dorsolateral prefrontal cortex (DLPFC) during 10 daily treatments within two weeks then 6 more treatments during the following month. | Device | Treatment rTMS + meth pictures, Treatment rTMS + neutral pictures |
| Sham Repetitive transcranial magnetic stimulationA sham magnet will be used during rTMS treatments, which will look identical to the real magnet. The participants and treatment facilitator will be blinded to which magnet will be used. The sham rTMS treatments will be directed at left dorsolateral prefrontal cortex (DLPFC) during 10 daily treatments within two weeks then 6 more treatments during the following month. | Device | Sham rTMS + meth pictures, Sham rTMS + neutral pictures |
| Methamphetamine visual cuesJust before each rTMS session, participants will be shown methamphetamine-related pictures | Behavioural | Sham rTMS + meth pictures, Treatment rTMS + meth pictures |
| Neutral visual cuesJust before each rTMS session, participants will be shown neutral pictures | Behavioural | Sham rTMS + neutral pictures, Treatment rTMS + neutral pictures |
Primary outcome
Effect of rTMS directed at left DLPFC on craving for methamphetamine as assessed by the Severity of Dependence Scale.
Time frame: 6 weeks
The Severity of Dependence Scale (SDS) is a 5-item questionnaire that provides a score indicating the severity of dependence on methamphetamine. Each of the five items is scored on a 4-point scale (0-3). The total score is obtained through the addition of the 5-item ratings and will range from 0 to 15. The higher the score the higher the level of dependence. Pre and post differences in craving will be assessed.
Effect of rTMS directed at left DLPFC on craving for methamphetamine as assessed by a Visual Analog Scale (VAS).
Time frame: 6 weeks
The visual analogue scale (VAS) is a fixed-length horizontal line on which the participant draws a line between the two anchors of "no cravings at all" and "most intense craving imaginable". The distance between the "no cravings at all" anchor and the participants line is measured and reported as a value between 0 and 100. The higher the value, the more intense the participants cravings are. Pre and post differences in craving will be assessed.
Effect of rTMS directed at left DLPFC on craving for methamphetamine as assessed by the Stimulant Craving Questionnaire (STCQ).
Time frame: 6 weeks
The Stimulant Craving Questionnaire-Brief (STCQ) is a 10-item self-report measure that assesses current craving for methamphetamine, using a seven-point scale, with answers ranging from 0 ("strongly disagree") to 6 ("strongly agree"). A composite score is generated for each participant by averaging the responses over all 10 questions. The scores can range from 0 to 6. The higher the composite score, the stronger the current craving. Pre and post differences in craving will be assessed.
2 secondary outcomes
Effect of craving for methamphetamine on relapse status after rTMS directed at left DLPFC.
Time frame: 5 months
Effect of cue type (methamphetamine versus neutral) on methamphetamine craving after rTMS treatment.
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Holly McCready contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real Repetitive transcranial magnetic stimulation, Methamphetamine visual cues and Neutral visual cues in people with Methamphetamine Abuse and Substance Use Disorders, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brandon J Cornejo, MD, PhD (503-721-7964, brandon.cornejo@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of rTMS directed at left DLPFC on craving for methamphetamine as assessed by the Severity of Dependence Scale. (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.